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July 3rd, 2012
02:02 PM ET
FDA approves first at home rapid HIV testThe first ever over-the-counter rapid HIV test has been approved by the Food and Drug Administration. Users of the OraQuick In-Home HIV Test swab their upper and lower gums with the included test pad device and place it into a vial of solution. Much like a pregnancy test, one line shows up if the test is negative, two lines means a positive test. Test results take about 20 minutes. A positive reading does not mean a definite human immunodeficiency virus, but that additional testing should be scheduled with a health professional. However, the FDA also cautions that a negative test result "does not mean that an individual is definitely not infected with HIV, particularly when exposure may have been within the previous three months." The FDA approved another in-home test in 1996, however those samples needed to sent away to a lab for results. According to the Centers for Disease Control and Prevention about 1.2 million people in the United States are currently living with HIV, but about one in five don't know they're infected. "Knowing your status is an important factor in the effort to prevent the spread of HIV," said Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research. "The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate." In clinical trials the OraQuick performed at 99.98% for test specificity–the percentage of results that will be negative when HIV is not present. This means that one false positive would be expected out of every 5,000 test results in uninfected individuals. A version of this test has been used by trained technicians in clinical settings since 2004. OraSure Technologies, the manufacturer of the OraQuick In-Home HIV Test will have a consumer support center that is available via phone and will be open 24 hours a day, seven days a week. The center will provide users with information about HIV/AIDS, the proper method for administering the test and guidance on what to do once results have been obtained. Douglas Michels, President and Chief Executive Officer of OraSure says the approval represents a major breakthrough in HIV testing. "For the first time ever, individuals will have access to an in-home oral test that will empower them to learn their HIV status in the comfort of their home and obtain referral to care if needed. This new in-home rapid test – the same test doctors have used for years – will help individuals at risk for HIV who otherwise may not test in a professional or clinical setting." Orasure expects the kit to be available in stores and online in early October. The professional version of the kit sells in clinics for $17.50 but Michels believes the home kit will cost a little more. He says the price will be set by retailers. More than 30,000 stores will carry the test when it launches, he adds. soundoff (774 Responses)1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Next »Leave a Reply to Eye Exam Phoenix
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Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.
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Great, will insurance cover the cost?
Why is it insurance compaines cover 'preventative' exams, but as soon as you are actually have a 'condition' IE high blood pressure the tests are considered 'diagnostic' and no longer covered by the insurance?
Is this a matter of the insurance company doing a 'profile' on you, to reduce their coverage?
It seems to me that if you have a condition that is treatable they would want to cover yearly tests to ensure the medication you are taking or the actions you are taking are in fact helping with the condition.
Again, is this profiling by the insurance compaines to save them money?????
Uh – because preventing a disease is much, much cheaper than treating a disease, for all involved. The insurance companies save money if they can prevent a disease from occurring, or by finding it early when it is still inexpensive to treat.
I don't know if Obamacare stops this particular abuse but the Big insurance companies have so many of them; Who could possibly keep track of them all? Big insurance loves the old way; Charge whatever they want, insure whomever they want, drop you whenever they want.
Thanks to ACA (Obamacare), insurance companies can no longer deny you coverage for pre-existing conditions...ACA is not so bad, is it?
No, they cannot deny coverage for pre-existing conditions. But they can refuse to pay for treatment.
Anything outside of the network they may refuse to pay for. There are tons of loopholes. The trick is picking the coverage you need and the network you need before you need it. Alot of people will be getting screwed. Insurance companies make deals with pharma companies. If you can't get the kind of medicine made by that company then you have to pay out of pocket. If an insurance company doesn't have contracts with your hospital, amublance, doctor, then the insurance company doens't have to cover it. Basically you need to pick when, where and how you get sick.
Another thing that sucks. Since Obamacare was passed, before it went to court, I've been to the hospital about 5 times. Neither of those times was my medicines were covered by insurance. Rules changed the minute Obamacare passed, and not for the better.
I wonder how many people will get a positive test and decide to kill themselves before having a second test done professionally? I know I would.Maybe this is not such a good idea.
And why would you do that, when it is clearly stated that a "positive" test simply indicates that a more definitive test should be done? Even those more rigorous tests, by the way, have a small percentage of false positives – and negatives. There is no test in medicine that is 100% accurate.
Really! I'll watch.
HIV isn't the death sentance it used to be. There have been many advances in medication and treatment that can greatly prolong your life and/or reduce your viral load to undetectable levels. Access to medication and treatment is often the determining factor in survival, not the disease itself.
Any sensible person would get tested by a doctor before panicking. The better question would be- how many people test negative when they are actually positive. I didn't see that inthe article.
HIV is a manageable disease. It's not like it was before antiretrovirals in the 80's. It's treated more like a chronic condition now. I work around people with HIV and they seem happier, wiser, and more accepting of things than a lot of uninflected people I know. This new test kit will allow people that do not like going to clinics get tested. People that know they are infected are 60% less likely to transmit the disease. It will give people peace of mind and will identify positives quicker.
A "reasonable" (read: not panic stricken) person would probably go to the public health department (free test) or to their doctor to get an HIV test. So, I think it's fair to assume the person who runs out to CVS or Walgreens at 2 AM to purchase one of these might not be in a "reasonable" frame of mind. Of course, most of them are doing this out of hypochondria or guilt and will test negative, but there will be a few who test positive. Those are the unreasonable people who might kill themselves.
Why wait for your test results...do it NOW!
Because of the high specificity of this test, if a person gets a positive result they are highly likely to actually have HIV. Further testing is recommended because no test is certain, but a specificity of 99.98% is incredibly high and in most cases will mean the virus is present. Too bad we don't know the sensitivity, because I am more worried about the number of false-negative tests (persons who receive a negative result but do have HIV).
To amend my statement though, we need the PPV to really know how well this test can accurately determine true HIV status. I say this because if the prevalence of true positives is also 1 in 5000, then a person has a 50% chance that their positive result is incorrect.
@KLUR- Really? Did you read the article?
"In clinical trials the OraQuick performed at 99.98% for test specificity–the percentage of results that will be negative when HIV is not present. This means that one false positive would be expected out of every 5,000 test results in uninfected individuals"
.02% test neg, when actually positive.
@ALA
Please re-read what you quoted, it is saying there is .02% of those without the disease test positive, or .02% chance of false positives. The article says nothing about sensitivity or false-negatives.
KLUR is correct.
The home HIV test might have unintended consequence. I can picture someone who tests positive at home, deciding to spread it around a bit, 'I don't want to be alone, will spread it around as I can so others will suffer with me.'
It's $18 stop being such a cheap leftist. Christ almighty stop bleeding the system dry.
Genius. Don't have bigot kids. They will be gay and have sex with aids infected black people.
Halleluhah!!!
Hallelulah!
Hallelulah to Sekonda Huet's comment. (Since my comment is getting placed in the wrong place)
I could have made a test for way cheaper, it would consist of: 1 piece of paper, 2 questions: 1. are you black? 2. are you gay?
if you answered yes to all questions, you should find medical attention immediately from Dr. Kevorkian and associates
genius123, Im truly sorry that you do not like black or gay people! it's a shame that sometimes when people hate others it's because they hate something about themselves. get out of your small secluded world and wake up to reality.
That is so crass! "Genius"? I don't think so...
genius1233 – Your hate is sad.
In a perfect world a genius could count past 3.
It's okay, most people also don't like gays or blacks. At least they are perfectly aware of it, every time they have to leave their home.
If any of your friends have told you that you are funny, they should stop. Someone needs to quit enabling you.
Funny and original. You forgot intravenous drug user though.
I actually find this development to be scary. If a person wasn't inclined to be seen and tested professionally, thenI really wonder how many people will discretely discover they're HIV positive and just slip themselves into a quite state of denial, not seeking medical treatment, continuing to engage in unsafe sex practices, spreading the disease further?! I much prefer the idea of people being tested by professionals with all positive results being reported and tracked by the CDC.
I understand your point, notsosure, however I believe the people that go into denial and continues their risky behavior are just as likely to continue their behavior after a clinical test as they would an at-home test; Result reporting or not, there is little to be done to address those people. We do not track positive individuals by branding them with a + sign after clinical testing, so it's still up to that person to tell their upcoming sexual partners they are positive.
This test is designed to address the population of people too afraid, by social stigma or what have you, to go into a clinic and be tested. I would hope that, upon receiving a positive result, the user would seek medical attention for their own well being and then it would be further reported to local health authorities for epidemiological purposes. Ideally, the at home test will provide a more accurate picture of HIV statistics as more positive people come forward.
There will always be flaws with at-home testing for diseases, but I think all-in-all this is a good move by the FDA.
That type of person won't go and get tested professionally anyway. Their denial had begun much earlier than their positive test result and was probably the cause of their infection in the first place. I know plenty of people that don't know their status and don't want to get tested just because of fear and ignorance.
More worried about this one. Test comes back negative. WOOHOO! But, you're not. You're in the window period where you're actually infected but not showing positive yet since you haven't developed the antibodies that the test is looking for. Worse, you're also in that period where you're most infectious to another person. Instructions? Call center? I highly doubt most would call. They want to know if they are or aren't. They aren't going to be concerned with pesky little details like serconversion windows, viral loads prior to seroconversion, etc. Test reads negative, they're negative. This is a very scary development. Leave testing in the hands of the pros, where it belongs.
Not all states require you to tell them your life story when you get tested. Further, there are already OTC options that further, do not require registration. You don't give people enough credit and are obviously misguided. Perhaps you should check who is the #1 carrier of HIV in the US. Its not who you think it is, I guarantee it.
All good points. Another consideration is liability. There have been some cases where infected individuals have carelessly, even intentionally infected their partners with HIV and because there were medical records that proved they knew their "positive" status at the time they engaged with unsuspecting partners, they are now doing time in prison. Now someone can know they were positive and claim ignorance to such a crime. I'm still not so sure about this. It will be interesting to see how the cause and effect plays out with this one.
I don't think there are any laws against it
anything for a profit!
it occured to me you could make HIV test condoms that could indicate whether or not to switch back up and peal off in the time it takes to do the bum.
I am sure the liberals will cry until they get this for free as well.
And I'm sure the right wing nuts will blame everyone but their false god for things not going the way they planned when they've been praying so hard. Who is in denial here?
Oh, I agree it shouldn't be free. I'm not paying for someone else's HIV testing... Absolutely NOT. But I definitely think this product could save lives.
Reply to "J":
Are all right wing conservatives "nuts" in your book who believe in a "false God?" Perhaps, if some of us had faith and tried to live a more righteous life, this topic would not be necessary. There is good in the Godly and the Godless. Neither group is monolithic. That being said, I would wager a small bet that there are some "nuts" in your group's candy jar, as well.
Take care.
You're already paying for all of their food stamps, EBT cards, welfare, free public housing, free cell phones and monthly minute plans, childcare, etc., etc. Why stop there?
You're already paying for many HIV tests, anyway. In every city or town where I've ever lived, the public health department offers free testing.
Well, it all depends if there is an open cut. If I poerud dirty blood all over my hand and didn't have an open cut, I would not get HIV. Although the mouth is a bit different. The mouth usually has many cuts due to the teeth constantly biting down on the tissue inside your mouth. So, if you didn't have an open cut in your mouth you should be fine. But to be on the safe side, I would get checked out.And don't listen to the a** hole saying your going to die, there just ignorant, and don't know the basiscs of the question. It's kinda sad that they are saying it
Reblogged this on Well Behaved Women Rarely Make History and commented:
This is actually quite a big deal. There's a lot of stigma around just getting tested for STDs, and I'm personally in favor of DIY methods where people can take control of their own health. AND- fun story, I was part of the clinical trials for this particular product several years ago, so it's kind of awesome to see it finally on the market.
From home pregnancy test kits to home rapid HIV tests ? That's what Feminism ("sexual liberation") and rampant promiscuity gets you. STDs and HIV/AIDS will only spread in a culture of sexual irresponsibility and w h o r e d o m. But we have the freedom to do whatever and whomever we want right ? If anything happens we can always fall back on Obamacare, Abortions, Contraception Pills, tax payer funded insurance and medication, and now home HIV tests.
Sexual irresponsibility?!?? LOL Who the heck are you to tell me how to live my sex life?!? Just because you can't get any doesn't mean the rest of us can't have fun. Mind your own business!
Syphillis was one of the leading causes of death in Europe in the 15th and 16th centuries. So, sexual irresponsibility, maybe, but it is hardly a new problem.
MrSheep – How is feminism in any way related to promiscuity?
If one cannot see the connection between women and promiscuity, then I just don't know what to tell you.
I always laugh at the vast majority of "conservatives" who are so quick to judge the private behavior of others and rant that, essentially, morality must be legislated, and then in the same breath talk about how the "socialists" (nee liberals...because liberal isn't derisive enough anymore) want to take their freedom? Does anyone else see the disconnect, or rather hypocrisy in this?
You are absolutely ridiculous. Not every one who buys a home pregnancy test is being sexually irresponsible. My husband and I were TRYING to conceive and I bought numerous tests along the way in hopes it would be positive. Your right wing generalizations are sickening.
I completely agree with MrSheep. It is a fact that if you don't have sex outside of marriage and don't shoot drugs your chances of contracting this disease are effectively 0.
I live on a small island in the Pacific Ocean. We have anonymous and free testing at several locations on the island offered by the Maui AIDS Foundation. If a test is positive there is counseling and services provided free of charge. The Department of Health does the same thing. So many of these comments sound like the people on the mainland have no resources. All large cities have testing available with services available. Do the home test, freak out, then seek counseling and services.
I don't need it .... am not promiscuous and don't abuse drugs ... am truly monogomous for over 40 years.
you may have been monogamous but you can not say for sure whether your 40 year partner was... you can hope, that is all.
Unfortunately, there are thousands of married people all across the world who are living with HIV because they believed there partner was also monogamous.
Its a good test not even dr.an todays medical people dont know half the stuff they say they do an thats fact a dr. friend of mine told that an many other facts thats why its call practicing medicine an to the dumb people some types of aids kills fast an there many diff. kinds of aids its about time u can test a person before u have sex cause so many u doing every one an their family . be smart an keep the same mate dont hate keep only one date b4 its to late ?
dang....dang...that is all i can say to your post. Please don't give advice if you can't speak or write properly.
I have to say, for those of you who are concerned about people being in that "3 month window" before this test would conclude that they are indeed HIV positive, just remember this: YOU and anyone else can prevent this disease from entering your body. Use a condom. Yes, some people COULD wrongfully think they're disease-free when they aren't and unknowingly infect someone. That newly infected person could have used a condom. Yes some people may discover they do have HIV and not care, and go on to infect someone purposely. That newly infected person could have used a condom. We all have the power to prevent this disease from infecting us in these situations. That said, I think this is a great tool and kudos to the FDA for finally approving it for at-home use. We should never vote to keep people in ignorance for fear of what they might do with the information given.
Condoms are in no way 100% effective at stopping the transmission of AIDS. Just sayin'.
He's right: condoms are NOT 100% effective. Don't have sex before you're married and don't shoot drugs and you're basically immune to this disease.
Honey? Is it pink, or blue?
It's ... green ...
"those samples needed to sent away to a lab for results."
Does editing occur any more?
In my State there is no Anonymous testing. There is only Confidential Testing. If a person tests Positive, their name, address, phone number is immediately reported to the local board of health by their physician or the testing center. They are then contacted by the Board of Health for the names of all their sexual partners who are then contacted by the State or County Board of Health and informed that they may have been exposed to HIV. This is too frightening for many people to go in and be tested. The State promises confidentiality but it is not. A Home Testing kit provides a safety valve for someone to find out what their status is without putting their life at risk and allows them to then pursue other medical options.
Lmao So what your saying is a home test is better because then the health department won't contact your sex partners??? Shoulnd't they know so their lives are not also at risk? and so they can get proper timely treatment?! Selfish much!!!
But will it be available for blacks to purchase on their EBT cards? Now THAT'S the real question.
Lol u r dumd. How could they purchase a aids kit with a E.B.T. Card. Where I live I see a lot of my own race n Spanish using these cards. So I don't think it's only those african American any more we have caught up. I don't think poverty chooses a race before it hits.
What if we're black work most of our lives, and never obtained an EBT???
Are you aware that there are also poor white people?
The west hollywood health clinic stop using this exact test because of its failure percentage. Ora quick also makes the same test where you put one drop of blood on the paper and 15 mins later you know and has a 99.9% accuracy !
This is more of Big Pharma letting people get infected so they can sell them the drugs for their whole lifetime, instead of making a good test available at every bar and liquor store so that before you go to bed and don't know the person's history at least you would know if they had HIV !
Its the same test by the same company with an almost perfect result yet its in Big Medicines interest and NOT YOURS to keep the better test in mothballs and dr's offices where they can make $100 by selling to drs instead of you !
THATS YOUR DEATH PANEL – BIG PHARMA !
LOL
//A positive reading does not mean a definite human immunodeficiency virus, a negative test result "does not mean that an individual is definitely not infected with HIV//
tell me again why you are even doing this test?
To be fair, the test has a failure rate of about 1 in 5000. That being said, if any gay or black gets a negative reading, then according to the odds, they are that 1 in 5000, and should test again. And again. And again.
Truth – Why do you keep bashing gays and blacks? ANYONE can get infected with HIV if they have uprotected sex. Go crawl in a hole somewhere and stay there please. I'm a white straight woman is deeply embarrassed by your off color remarks as you are the reason we still have discrimination and racism issues.
This is a great step ahead.. Lets appreciate the good work they are doing!
i think its such a good idea. people are a bit shy when asking their physician to get tested.
So a positive result means you might be infected but might not be. A negative result means you might not be infected but you might be. So the point of this test is...?
You're better off going straight to a doctor and avoiding this test altogether and saving your money and peace of mind.
The flip side is "Clinical studies for self-testing have shown that the OraQuick In-Home HIV Test has an expected performance of 92% for test sensitivity, the percentage of results that will be positive when HIV is present. This means that one false negative result would be expected out of every 12 test results in HIV-infected individuals."
A positive reading could be false, and a negative one does not mean the virus is not present.
Sounds like a real useful test.
What people fail to realize is that this is the SAME screening test they at your doctor's office or you local clinic. This is a simple way to know if you have it or not. Most of you people jump to that if they find out that their positive they might kill them selve the truth is that it doesnt matter where you take the test and find out your positive and you want to kill your self then you will no matter if you take the test at home or at the doctor's office. ANYONE can get HIV and for all the bible tumpers out there "St. Matthew 7 Judging Others Lk. 6.3738, 4142 Judge not, that ye be not judged. For with what judgment ye judge, ye shall be judged: and with what measure ye mete, it shall be measured to you again. Mk. 4.24 And why beholdest thou the mote that is in thy brother's eye, but considerest not the beam that is in thine own eye? Or how wilt thou say to thy brother, Let me pull out the mote out of thine eye; and, behold, a beam is in thine own eye? Thou hypocrite, first cast out the beam out of thine own eye; and then shalt thou see clearly to cast out the mote out of thy brother's eye. Give not that which is holy unto the dogs, neither cast ye your pearls before swine, lest they trample them under their feet, and turn again and rend you."
So it really comes do to is what would you do to save your own life.
Truth – Please change your name to Ignorant, because that's exactly what you are. Your comments have absolutely no basis. You're sitting behind a computer scren amusing no one but yourself. Get a life! Pick up some books and try to open that little mind of yours. Racist comments doesn't hurt anyone but the person making the comments. It shows how silly and uneducated you are. Better to be thought of as a fool than to open your mouth (or in your case, post a stupid comment) and remove all doubt.
Get your Krusty the Clown Do-It-Yourself HIV Home Test Kit today! Side effects may include severe bleeding, abdominal craps, ulcers, constipation, diarrhea and HIV.
Seriously awesome! Oh, wait, we have that for HCG already and nothing means anything with out a doctor. Skip this and don't abuse needles and have unsafe sex! HCG pops for other things other then pregnancy and we will find other things that pop for HIV I'm sure.
For an extra $25 the vendor will include a Zip Gun so you can kill yourself after seeing the results of the test.
I'd say that the majority of HIV/AIDS cases in the United States are easily preventable. Don't have sex outside of marriage and don't shoot drugs. Have some self control. When you behave like lusting animals, you get diseases like this.
I'm split on my opinion – I believe it's very important to get tested and know – early treatment is the best option in controlling the disability – yet doing it in private presents 2 problems – #1 – When tested in a clinic, counseling is available (mandatory usually), and #2 – CDC will not have access to the information, so they will be unable to determine trends of new infected patients – and possibly skew statistics which could negatively impact federal funding for prevention and treatment programs.....hmmmmmm......
This ad is from 2012 and it has been proven that oraquick is not accurate. You can get other internet order hiv tests, find out the results next day, and they will be accurate because they do confirmatory testing to confirm those results. Also if you have an infectious disease please go to your doctor or clinic. Also tell all others you have had sexual contact with about the possibility that they too can also be infected.
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